Penicillin G Procaine,Dihydrostreptomycin Sulfate,and Prednisolone Injectable Suspension
»Penicillin G Procaine,Dihydrostreptomycin Sulfate,and Prednisolone Injectable Suspension is a sterile suspension of Penicillin G Procaine and Prednisolone in a solution of Dihydrostreptomycin Sulfate in Water for Injection.It contains one or more suitable buffers,dispersants,preservatives,and suspending agents.It may contain not more than 2.0percent of procaine hydrochloride,and one or more suitable stabilizing agents.It contains not less than 90.0percent and not more than 115.0percent of the labeled number of Penicillin G Units,not less than 90.0percent and not more than 115.0percent of the labeled amount of dihydrostreptomycin (C21H41N7O12),and not less than 90.0percent and not more than 110.0percent of the labeled amount of prednisolone (C21H28O5).
Packaging and storage— Preserve in single-dose or multiple-dose,tight containers.
Labeling— Label it to indicate that it is intended for veterinary use only,and is not to be used in animals to be slaughtered for human consumption.
Identification— It responds to Identificationtests Aand Bunder Penicillin G Procaine,Dihydrostreptomycin Sulfate,Chlorpheniramine Maleate,and Dexamethasone Injectable Suspension.
Bacterial endotoxins á85ñ— It contains not more than 0.01Endotoxin Unit per 100Penicillin G Units.
Other requirements— It meets the requirements of the test for Sterility,and for pHunder Penicillin G Procaine and Dihydrostreptomycin Sulfate Injectable Suspension.
Assay for penicillin G—
Standard preparation— Using USP Penicillin G Potassium RS,prepare as directed for Standard preparationunder Iodometric Assay—Antibiotics á425ñ.
Assay preparation— Dilute an accurately measured volume of Injectable Suspension quantitatively with Buffer No.1to obtain a solution containing about 2000Penicillin G Units per mL.Pipet 2mLof this solution into each of two glass-stoppered,125-mLconical flasks.
Procedure— Proceed as directed for Procedureunder Iodometric Assay—Antibiotics á425ñ,except in the Blank Determinationto add 0.1mLof 1.2Nhydrochloric acid immediately before the 10.0mLof 0.01Niodine VS.Calculate the quantity,in Penicillin G Units,in the portion of Injectable Suspension taken by the formula:
(L/2D)(F)(B-I),
in which Lis the labeled quantity,in Penicillin G Units,in the volume of Injectable Suspension taken,Dis the concentration,in Penicillin G Units per mL,of the Assay preparation,on the basis of the labeled quantity in the portion of Injectable Suspension taken and the extent of dilution,and the other terms are as defined therein.
Assay for dihydrostreptomycin— Proceed as directed for the turbidimetric assay for dihydrostreptomycin as directed under Antibiotics—Microbial Assays á81ñ,using an accurately measured volume of Injectable Suspension diluted quantitatively with water to yield a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.
Assay for prednisolone—
Standard preparation— Prepare as directed for Standard Preparationunder Single-steroid Assay á511ñ,using USP Prednisolone RS.
Assay preparation— Transfer to a separator an accurately measured volume of Injectable Suspension,and add 15mLof water.Extract with three 25-mLportions and finally with one 20-mLportion of chloroform,filtering each portion through chloroform-washed cotton into a 100-mLvolumetric flask.Add chloroform to volume,and mix.Pipet 20mLof this solution into a suitable glass-stoppered flask or tube,evaporate the chloroform on a steam bath just to dryness,cool,and dissolve the residue in 2.0mL,accurately measured,of a mixture of equal volumes of chloroform and alcohol.
Procedure— Proceed as directed for Single-Steroid Assay á511ñ,using Solvent Ato develop the chromatogram.Calculate the quantity,in mg,of prednisolone (C21H28O5)in each mLof the Injectable Suspension taken by the formula:
0.01(C/V)(AU/AS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 1494
Phone Number:1-301-816-8178